Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Harvoni

Harvoni 90 mg/400 mg film-coated tablets Harvoni 45 mg/200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 16–17

HOS-132258 · Präparat HOS-097208

16  Medicinal product by Effects on medicinal Recommendation concerning co-administration therapeutic areas product levels. with Harvoni Mean ratio (90% confidence interval) for AUC, Cmax, Cmina, b Elvitegravir/ cobicistat/ Interaction not studied. When given with elvitegravir/ cobicistat/ emtricitabine/ tenofovir Expected: emtricitabine/ tenofovir disoproxil fumarate, disoproxil fumarate ↔ Emtricitabine Harvoni is expected to increase the concentration of (150 mg/ 150 mg/ 200 mg/ ↑ Tenofovir tenofovir. 300 mg once daily)/ ledipasvir (90 mg once Observed: The safety of tenofovir disoproxil fumarate in the daily)c/ sofosbuvir (400 mg Elvitegravir setting of Harvoni and a pharmacokinetic enhancer once daily)c ↔ Cmax 0.88 (0.82, 0.95) (e.g. ritonavir or cobicistat) has not been ↔ AUC 1.02 (0.95, 1.09) established. ↑ Cmin 1.36 (1.23, 1.49) The combination should be used with caution with Cobicistat frequent renal monitoring, if other alternatives are ↔ Cmax 1.25 (1.18, 1.32) not available (see section 4.4). ↑ AUC 1.59 (1.49, 1.70) ↑ Cmin 4.25 (3.47, 5.22)

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): tenofovir (HOS-088083) cobicistat (HOS-088111) fumarate (HOS-108845) tenofovir disoproxil fumarate (HOS-110471) ritonavir (HOS-084521) elvitegravir (HOS-088110) emtricitabine (HOS-085840)